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Tuesday, March 19, 2013

Doctors' Dubious Excuses for Taking Pharmaceutical Companies' Money

Pro Publica has updated their database of payments by pharmaceutical payments to physicians and organizations. It now has data from 15 companies totaling more than $2 billion from 2009 to 2012.

The combined reports showed that many physicians, including prominent academics and community practitioners, are still getting a lot of money from pharmaceutical firms. Since Pro Publica was only able to get data from some US drug companies, albeit those who accounted for 47 percent of US drug sales, it is likely that many more doctors than those in the data base got such payments, and the doctors in the data base may have gotten more money from companies that do not report their payments. In addition, it is likely that many more doctors get similar payments from medical device companies, health care information technology companies, and other for-profit corporations that promote health care products and services.

We had discussed Pro Publica's initial reporting from its database here. While there is evidence that most payments to doctors by pharmaceutical companies are intended to promote marketing, we discussed here how some doctors rationalized their payments as fully professional and proper.

Now the updated reporting has provided many examples of - not to put too fine a point on it - physicians making dubious excuses for their acceptance of payments, often large, from pharmaceutical companies. Their themes included

It's Education, What Could Possibly Go Wrong?

From Pro Publica,

[Dr Rakesh] Jain, of Lake Jackson, Texas, has earned $582,049. [Dr Vladimir] Maletic, of Greer, SC, made $527,850, according to Dollars for Docs.

So,

Jain said he loves teaching and delivers the same lectures about
drugs and medical conditions regardless of whether a drug company is
paying him.

'I am not a marketer, I am an educator,' Jain said.

Also

Maletic said he speaks about treatments for mood disorders,
schizophrenia and sleep-wakefulness disorders because he believes that 'good quality education about pharmaceutical products may be beneficial
to both physicians and their patients.'

The LA Times found someone with a similar opinion.

'Pharmaceutical
companies used to take doctors to dinner, but that was banned years
ago,' said Dr. Arthur Chanzel Jeng, an infection control specialist at
UCLA-Olive View Medical Center in Sylmar. 'Now they must provide some educational content.'

Jeng was paid $80,500 by Pfizer last year for several speaking
engagements. As an infection control specialist at Olive View, he and
others in his field are concerned about drug resistant diseases and the
limited number of antibiotics. Drug companies have little incentive to
produce new antibiotics, he said, so if they do, physicians in his field
want to know more about the drugs. That's why he agrees to speak.

'We (speakers) provide education when a new antibiotic does get
released,' he said. 'There needs to be education among doctors on how to
use this new antibiotic.'

In addition, the Salt Lake Tribune noted that

[Dr Eliot] Brinton received two of the single largest
payments in Utah, both in excess of $85,000, for promoting drugs by
GlaxoSmithKline, ProPublica’s database shows. He describes the lectures
as educational and based on science.

'I love the science and I love to teach. And
doctors are glad to better understand the drugs and how to use them. I’m
careful not to act as a cheerleader,' he said. 'If I’m a shill for the
drug company I lose my integrity and integrity is really all I have to
offer my patients and the drug companies.'

The physicians above all asserted that since their activities were "educational," they must be worthwhile.

Note that the ostensibly educational activities described above all appear to be "drug talks," that is talks sponsored by the drug companies, probably through speakers' bureaus, and given probably not as part of formal, accredited continuing medical education. Since the publication of "Dr Drug Rep" in the New York Times in 2007, the public has learned that such talks mainly include content provided by the pharmaceutical companies, and are meant by the companies as marketing exercises. From that case we also learned that physicians who deviate from the marketing message do not last long on speakers' bureaus. (See posts here and here.)

In addition, pharmaceutical companies often pay physicians deemed to be "key opinion leaders," whose opinions are promoted supposedly for their brilliance and erudition. However, as noted here and here, the companies buying their services believe they have bought the services of sales people. Evidence about key opinion leaders actually performing like marketers has come from documents revealed during litigation (e.g., see this recent example of a huge monetary settlement made of charges that GlaxoSmithKline, a major multinational drug company committed fraud among other things, and in the course of its unethical activities used key opinion leaders as marketers). Also, see the Neurontin marketing plan (see post here), and the Lexapro marketing plan (see post here) for examples of how company keaders view key opinion leaders as marketers.

Given the volume of evidence about drug talks, speakers' bureaus, and the marketing purposes of key opinion leaders, the assertion that because they were in some sense educational, these doctors' corporate financed talks were worthwhile is at best a silly excuse.

More formally, it may arise from a logical fallacy. The doctors appeared to be arguing that education is an unalloyed good. However, obviously not all education is good education, or unbiased education. Specifically in this case, logic, and evidence from several cases in which pharmaceutical companies' intentions as documented in communications revealed in litigation (see examples here) suggest that these companies pay physicians for education that they believe serves marketing purposes.Thus the doctors seem to be using the composition fallacy, the logical fallacy that an entire class (in this case, all of education) can be judged by some of its members (examples of unbiased, accurate, good education.)

It's Research, What Could Possibly Go Wrong?

Similarly, the doctors who get paid to do research say it's all about the research. The Salt Lake Tribune reported on

CRI LifeTree Research, which has received at least $3.4 million in drug company payments since 2009, according to ProPublica.

Co-founder Lynn Webster,
an anesthesiologist, is listed as having received the single largest
payment in the state: $1,687,771 from Cephalon, a big maker of pain
medications. Only three other doctors in the country received more from
Cephalon.

Nationally, Webster is among the top 50 for
single largest payments received, behind marquee hospitals, such as the
Mayo Clinic, Cleveland Clinic and Duke and Harvard Universities.

A nationally recognized expert in pain management, Webster is under investigation
by the U.S. Drug Enforcement Administration, which is looking into
opioid overdose deaths of patients of his former pain clinic. A Senate
Committee is probing his financial ties to Big Pharma.

Webster insisted,

Research payments to him cover overhead and other costs, including his salary as a lead researcher, he said.

'What I'm doing for Allergan is to advance breast surgery,'
said Gross, a board certified surgeon and a former chemical engineer. 'Much of the research you do is industry-supported. They have a
motivation to make better and new products.'

It is pretty amazing to see the notion that all clinical research is irreproachable in print. We and others have documented huge numbers of cases and volumes of evidence that clinical research may be manipulated, and, if necessary, suppressed to support the commercial goals of those who make products or provide services assessed by such research. In fact, the prestigious Institute of Medicine's report on Conflict of Interest in Medical Research, Education and Practice included the recommendation (4.1) that "individuals may not conduct research with human participants if they have significant financial interest in an existing or potential product or a company that could be affected by the outcome of research." Given the volume of this evidence, the assertion that all pharmaceutical company clinical research should be irreproachable is just plain silly.

Again, formally the physicians' arguments, if they should be dignified with that name, seem to arise from the same logical fallacy discussed above. The underlying argument seems similar to that made above about education: "I am doing research. All research is good, unbiased, helpful to patients. So what I am doing is good, unbiased, helpful research." So it appears the composition fallacy again was in play.

It's Not Really My Money

The San Jose Mercury News provided this example,

The database links Dr. Gurkirpal
Singh to more than $248,000 in Pfizer payments it lists for speaking,
consulting, travel and meals since 2009. He said all the money went to
Institute of Clinical Outcomes Research and Education in Palo Alto,
where he is the chief scientific officer. Singh said the money paid for
research.

'I receive nothing -- let me be very clear on that,' said Singh, who is an adjunct clinical professor at Stanford University.

The Columbus Dispatch added,

Dr. Henry Nasrallah, a psychiatrist at the University of Cincinnati,
netted $647,341 in speaking and consulting fees from drug companies,
ranking him as Ohio’s top recipient of such payments over that four-year
period. Cincinnati’s College of Medicine put that money toward his
$222,232 annual salary.'The (pharmaceutical) companies have a signed agreement with the
university for my activities, not with me personally,' Nasrallah wrote
in an email to The Dispatch.

'This is another reason why I maintain scientific and clinical
impartiality about the various drugs I teach, because I do not have a
direct personal gain,' wrote Nasrallah, a former chairman of Ohio State
University’s psychiatry department.

Really, the boss doesn't care whether he brings in any money?

These doctors seem to be denying that money is fungible. In other words, they seem to be arguing that money going to the organizations that pays them is different from money going directly to them, and that their bosses do not in fact care whether their activities bring any revenues to the organization. This just flies in the face of common sense.

Someone Needs to Pay

NewsChannel5 was able to interview the top earner on the Pro Publica list, Dr Jon W Draud, who said among other things,

it was only fair to accept payments for his speaking engagements
because it makes up for what he would otherwise make while working at
his practice.

'It's not essential, I suppose, but I consider it a reasonable, fair
compensation for being gone and traveling, and spending time away from
my home and family,' Draud said.

If Dr Draud was providing education, a useful service, it seems reasonable that someone should pay for it. However, he appears to beg the question of who should pay for it? Underlying this question is the concern that since it was pharmaceutical companies, not students, who were paying, the education was being done primarily to benefit the former, through marketing, rather than the latter. The apparent argument, that because it is not reasonable to get paid for services, any source of payment is acceptable, is again just plain silly.

Who Cares About Money?

NewsChannel5 also reported that Dr Draud said

accepting so much money did not create a conflict of interest between
him and his patients. He said the information he gives out was not
biased towards the drug companies.

However, the Institute of Medicine report on Conflict of Interest in Medical Research, Education and Practice defined conflict of interest as "circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest." Asserting that receiving over $1 million could not create even a risk that his educational presentations were biased towards the interests of those who gave him that money seems like simple denial.

The FDA Said it Was True

Top earner Dr Draud also said according to NewsChannel5,

It has to be vetted by the FDA as being fair, balanced and non-biased toward the pharmaceutical company....

From the Philadelphia Inquirer, re Dr Warren S Joseph, a podiatrist who received over $650,000

Joseph acknowledged the payments in an email to Philly.com.

'All
of my lectures given for the Pharma industry follow strict
FDA guidelines and are consistent with the corporate integrity
agreements entered into between the companies and the government,'
Joseph said. 'There is full disclosure of this fact at all lectures.'

These justifications appear to be just plain wrong. As far as I know, the US Food and Drug Administration does not pre-approve "drug talks" given by physicians for pharmaceutical companies.

By the way, the statement by Dr Joseph approaches self parody. As we have discussed, corporate integrity agreements are usually the products of legal settlements of charges of wrongdoing. Drug companies do not sign such agreements because of previous good behavior. Moreover, I have never heard of such an agreement that required pre-approval of drug talks, either.

Trust Me, I'm an Expert

As reported by NorthJersey,

One of the top recipients in North Jersey was Thomas Dayspring, an
internist and expert in cholesterol management, who earned just under
$400,000 from Merck and GlaxoSmithKline. Dayspring said he was paid for
lectures at conferences for doctors arranged by the drug companies, as
well as continuing medical education programs.

'I’ve logged over 2 million miles, all over the world
and in all 50 states,' said Dayspring, who served as the director of the
North Jersey Institute of Menopausal Lipidology in Wayne
until last summer. 'Guys like me who are nationally known attract a big
audience. Not every speaker can trot out a CV like mine.'

New Jersey, you gotta love it. The most charitable characterization of this is an appeal to authority, albeit an amazingly egotistical one.

Summary

Two years after Pro Publica's report, pharmaceutical companies are continuing to pay substantial sums to physicians and other health professionals, nominally for education and research. Because these arrangements are financially beneficial to the professional recipients of the money, and likely financially beneficial via their marketing effects to the companies that provide the money , it should be no surprise that they are continuing in the absence of any regulatory restrictions.

What is saddest about the latest reporting is the silliness of the excuses made by the conflicted physicians. Professionals with four years of education post-college, and multiple years of experience, and who are often respected as academics or practitioners ought to be able to reason and argue better than they did in the examples above. Of course, people who make a lot of money often come to believe they really deserve it. And conflicts of interest produce conflicted thinking. As Joe Collier wrote in the BMJ, " people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." (Look here.)

The IOM report on conflicts of interest suggested full disclosure of all payments that could be considered conflicts of interest, banning clinical research by conflicted individuals, prohibiting academic physicians from giving "drug talks" whose content was provided by industry, and developing methods to fund continuing medical education independent from industry. This report, and its recommendations have gotten scant attention, maybe because they would threaten a status quo that enriches conflicted health professionals and the companies that create these conflicts. However, in my humble opinion, implementing all the report's recommendations would only be a beginning down the road of restoring the integrity of clinical care, teaching, and research.

2 comments:

Anonymous
said...

Equally irresponsible is the head of the ABIM who makes around $900,000/year by forcing internal medicine practitioners to participate in and pay for their maintenance of certification procedure. This procedure has no evidence to support its use, is forced on financially challenged internists, and is incredible overpriced. I would love to see you comment on that!

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